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NCT Number: NCT06975124

taVNS Effects on Fear Ratings in Naturalistic Context

During the fear rating task, 70 participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nirsit Lite

Chengdu, Sichuan, 611731, China

Location status: Recruiting

Location contact

Weihua Zhao, PhD

PRINCIPAL_INVESTIGATOR

Weihua Zhao, Phd

CONTACT

[email protected]

+86 18780247797

About this study

In a sham-controlled, participant-blinded, between-subjects design, 70 participants were randomly assigned to either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. The taVNS group received stimulation via a modified transcutaneous electrical acupoint stimulation device, with ear clip electrodes attached to the left cymba conchae to target vagus nerve branches. The sham group received identical electrode placement on the left earlobe, a non-vagus-innervated site. Stimulation intensity was individually calibrated to a perceptible but non-painful level to ensure vagal activation while maintaining participant comfort.

Upon arrival, all participants completed standardized mood and trait questionnaires. To assess emotional and physiological changes, two administrations of the Positive and Negative Affect Schedule (PANAS) and blood pressure/pulse measurements (pre- and post-intervention) were conducted. During the fear rating task, participants viewed a 600-second horror movie while continuously rating their subjective fear intensity (0-100 scale) every 0.51 seconds (1,170 total ratings). Functional near-infrared spectroscopy (fNIRS) data were simultaneously recorded using the NIRSIT LITE system to monitor cortical hemodynamic responses. Additionally, skin conductance responses were measured vy BIOPAC MP150 system.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy participants without color blindness, current or regular substance or medication use, any current or history of medical or psychiatric disorders and contraindications for MRI.

Exclusion criteria

  • Color blindness,
  • Current or regular substance or medication use
  • any current or history of medical or psychiatric disorders and contraindications for MRI

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

Ear clip electrodes attached to the left cymba conchae to target vagus nerve branches.

Sham condition

Device

Electrode placement attached on the left earlobe.

Primary outcomes

  1. Neural activity changes between groups

    Time frame: 10 minutes

    The differences in the activity of frontal regions between groups using fNIRS

  2. Fear ratings between groups

    Time frame: 10 minutes

    The differences in the fear ratings (0-100, from neutral to extremely fearful) between groups

  3. Functional connectivity witnin frontal regions between groups

    Time frame: 10 minutes

    The differences in the functional connectivity within frontal regions using fNIRS between groups

  4. The correlation between brain activity and behavioral ratings across groups

    Time frame: 10 minutes

    The correlation between brain activity and behavioral ratings across groups

Secondary outcomes

  1. Skin conductance response between groups

    Time frame: 10 minutes

    The differences in the skin conductance response during watching video between groups

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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